Raptiva Recalled in Canada

Date Published: Thursday, June 18th, 2009

Health Canada has reminded health care providers in that country that Raptiva is no longer available. The drug has been pulled from the global market because of its association with an often-fatal brain infection called progressive multifocal leukoencephalitis (PML). Raptiva was authorized in Canada in 2005 for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

PML attacks the brain and central nervous system and is usually fatal. It is caused by a polyomavirus, called the JC virus. The JC virus is often acquired during childhood. Most adults have been infected with the JC virus but do not develop PML. The virus appears to remain inactive until something (such as a weakened immune system) allows it to be reactivated and start to multiply. People with a weakened immune system or people taking drugs that suppress their immune system (immunosuppressants) are most likely to get the disease. Symptoms include vision problems, loss of coordination, and memory loss. Patients who survive the disease are often permanently disabled.

It was announced in April that Raptiva was being withdrawn from the global market. The decision was made because the risk/benefit profile for Raptiva had changed. There is no way to determine which Raptiva patients may be at risk for developing PML, and there is also no cure or treatment for the disease. Raptiva was no longer available in any market after June 8.

According to Health Canada, EMD Serono Canada Inc., the company that markets Raptiva in Canada, notified pharmacies and distribution centers on May 14, 2009 to return all remaining product. Supplies of Raptiva were quarantined on March 11, 2009 and no product has been shipped out since that date.

Health Canada has advised prescribers and other health care providers to continue to monitor carefully all patients that were taking Raptiva, for any signs or symptoms suggestive of PML, and/or other adverse effects.

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